Medical Research Is About to Slam Into a Wall

Medical Research is at risk of slamming into a wall if smart people outside of drug development do not get engaged. This is the conclusion reached by Katie Hood, CEO of the Michael J Fox Foundation for Parkinson's Research, in a posting this week at the Huffington Post.

Hood does a great job of breaking down the impact of a faltering economy upon an already strained system. Pharma is axing researchers. Biotechs are at great risk for bankruptcy. Venture capitalists are retreating. Government is not prepared to pick up the slack. Private foundations lack the capital or scope.

Is a new role for the public sector needed to ensure that the current 10-15 years to develop a new therapy does not get longer instead of shorter?


Co-posted from www.pharmasherpa.com

Study Refutes Claims on AIDS Drug Trials

Many were concerned that between the years 1985 and 1996, foster children in the NYC area were unwillingly subjected to clinical trials for H.I.V.

An investigation into the participation of New York City foster children in clinical drug trials for H.I.V. and AIDS over a nearly 20-year period has found no evidence that any children died as a result of the trials or that the foster children were selected because of their race.

Further coverage for this can be found:

Study Refutes Claims on AIDS Drug Trials New York Times
No Foster Children Died From Participation in New York HIV Drug ... Kaiser network.org
Study: NY Foster Kids Not Exploited for AIDS Research EDGE Boston

Stem Cell Based Clinical Trials Get the Green Light

According to this article on outsourcing-pharma.com the FDA has given the green light to first clinical trials of a stem cell based therapy. The clinical trials of the treatment GRNOPC1 uses stem cells to regrow damaged spinal cord cells in patients with acute spinal cord injury. The approval of this treatment comes at a time when George Bush is no longer the president. Now that Obama is in office, will we see more clinical trials approved by the FDA?

Clinical trials sharing information electronically

A new study by IntraLinks Poll shares that 50% of clinical trials professionals share critical information via email, 15% via fax and 14% via overnight courier.

Those considering using electronic means to share data were concerned about: security (40 percent), ease and flexibility of use (23 percent), speed of information sharing (17 percent), standardization across the enterprise (7 percent) and shipping/travel cost savings (7 percent).

Alison Shurell, the vice president of life sciences product marketing at IntraLinks had this to say about the new research:
"Executives may not realize that study start-up communication and management can be made simpler, faster and more secure by employing online solutions. Using an online workspace enables sponsors, CROs, sites, IRBs and others in a clinical trial to exchange information instantaneously in the most secure environment available. Our life sciences clients who have shifted the clinical trial process to an online solution have reported tremendous improvements in overall productivity and efficiency."

Acurian is Increasing Clinical Trial Information Virally

Allison Proffit at Bio-IT World discusses the new social media method that Acurian is using to increase awareness about clinical trials. The application, Click It Forward, runs on Facebook and MySpace was started by Acurian, it allows Facebook and MySpace members sign up, and then share the info with their friends. As a user’s friends sign up for Click it Forward, Acurian will donate money to one of 20 medical causes chosen by the user.

What do you think of Clinical Trials organizations looking to social media to increase awareness? We'd like to hear your thoughts.

GAO Criticizes the FDA’s ability to Oversee Clinical Trials

According to this post on outsourcing-pharma.com, the US Department of Health and Human Services has identified that the FDA has failed to provide sufficient oversight to ensure the protection of patients participating in clinical trials. This has in turn caused the GAO to conduct its own investigation of the FDA’s ability to oversee clinical trials, which started in 2007. The GAO is highly concerned that the FDA is not analyzing the impact age has on the safety and efficacy of the drug when the drug generally treats conditions for the more elderly.

Project Management in the Life Sciences: Results from a 2008 Survey and Comparison with Previous Surveys over the Last Decade

If you didn't have a chance to catch the web seminar "Project Management in the Life Sciences: Results from a 2008 Survey and Comparison with Previous Surveys over the Last Decade" with Dr. Jann Neilson of Wyeth, please do! It was a very informative session.

Check it out here:
https://www1.gotomeeting.com/register/403770168

About the web seminar:
The Project Management Institute Pharmaceutical Specific Interest Group has sponsored 50-plus item surveys in 2001, 2002, 2005, and in the fourth quarter of 2008. There have been up to 711 respondents to each of the surveys. We have determined people’s profiles (e.g. what country they live in), the organization’s profile (e.g. large pharma, small pharma, biotech, CRO, consultant, etc.), and most of the questions were about project management in the person’s organization.

The seminar will describe the most interesting data from the 2008 survey and how it compares to previous surveys. For example, there will be a comparison of how project management occurs in large pharma, small pharma and biotech. Differences in how project management is performed in the US vs. EU vs. Canada will be shown. Comparisons between virtual and defined project management groups will be explored. Single vs. multiple function project management groups will be contrasted. These and other comparisons will be made in order to shown how project management in the life sciences is performed. As a bonus we will compare compensation and vacations in the US, EU and Canada.

Updated Calendar of FDA Decisions and Clinical Trials

If you're in the world of Clinical Trials, you know how frustrating it can be to wait on the FDA approval or rejection of the pharmaceuticals you've worked on. Check out this post at Seeking Alpha that shows a handy way to see what decisions are slated to be made on certain drugs and clinical trials. What big decisions are you waiting on? We'd like to hear your thoughts.

Senator Criticizes Transparency Laws in Clinical Trials

According to this article on outsourcing-pharma.com, Senator Richard Moore has criticized laws in Massachusetts that enable pharma companies to hide payments made to physicians conducting clinical trials.

Moore believes that gifts and monetary compensation is public information and that it should not be hid from everyone. Moore later mentions:

“Patients and consumers generally have no idea what kind of relationships exist between their doctors and pharmaceutical companies or medical device manufacturers, relationships that result in billions of dollars per year in payments to health care practitioner.

Do you think that payments for physicians conducting clinical trials should be hid?

Clinical Investigators Financial Information

Released this month, The Food And Drug Administration’s Oversight Of Clinical Investigators’ Financial Information is now available. Read the document here.

Acurian raises clinical trials awareness with new social networking app

Acurian, a company who focuses on patient recruitment and retention software, has introduced a new social networking app. Click It Forward is a clinical trials and awareness tool that allows users of MySpace and Facebook. It will allow a broader audience to know more about recruitment for clinical trials.

The application works like this:
People register and install the free Click it Forward application on their Facebook or MySpace page, and then spread the application exponentially by inviting their online friends to install it. In doing so, they gain points based on how many friends subsequently install Click it Forward. The more points gained, the more money that Acurian donates to a selection of preferred medical causes selected by the user upon registration. The application also integrates Google™ Earth so that users can see a dynamic, visual map of their own Click it Forward network.

Source:
Earth Times

Clinical Trials Thrive Through an Economic Downturn

Bob Coughlin, the president of the Massachusetts Biotechnology Council, believes that even though we are in the middle of an economic downturn, clinical trials are going through an economic boom according to this latest post on Applied Clinical Trials.

The rest of the post highlights their huge success in 2008, showing that their annual growth rate in employment has risen to 12% and that they have nearly 2,000 ongoing clinical trials in Massachusetts with major companies like Novartis, Genzyme, Bristol just to name a few. Is your company experiencing the same growth during this time of recession?

New clinical trial at Johns Hopkins

MEMOTEXT will be tested for its effects on people with glaucoma. There will be 500 people recruited using telephone calls and text messages.

Amos Adler, president of MEMOTEXT, finds it to be an honor to collaborate on this special grant and believes this new interface will significantly improve medication adherence in patients with glaucoma. The company is confident this trial will demonstrate that their technology-driven adherence solutions help patients managing various conditions.

For more information on the trial, click here.

FDA Limits Interest in Clinical Trials

According to an editorial in yesterday's New York Times, the F.D.A has a seemingly limited interest in clinical trials--and this may be to the detriment of quality food and drugs that are created through these trials. For instance, its a federal requirement that the makers of drugs or medical devices receive financial information from the scientists conducting clinical trials before the trials start and to inform the F.D.A of any conflicts, yet fewer than 1% of of makers report any discrepancies. Someone is lining their pockets and the F.D.A is turning their heads.

From The New York Times:
The agency’s lax performance underscores the need for Congress to pass legislation requiring all drug and device makers to report their financial arrangements with doctors in a public databank. That would make it harder for clinical investigators or sponsoring companies to hide potential conflicts, including those that might bias clinical trials for the F.D.A. Do you agree with this editorial? What legislation should occur?

More Clinical Trials are Out of Compliance

Medical Product Outsourcing reports that the violation rate for clinical trial sponsors have gone up for the fiscal year of 2007, which has hit a 10 year high says the U.S. Food and Drug Administration.

Thirty three percent of the 40 clinical trial sponsors inspected by the center’s division of bioresearch monitoring were found to have some sort of regulatory violation, as opposed to 11 percent of 53 sponsors who were out of compliance the previous year. 2006 proved to be the best performance the industry had seen in 10 years. Can we expect 2008 numbers to produce similar results?

University of Kentucky starts new clinical trial

The University of Kentucky will start a clinical trial for an anti-seizure injection. They will be testing an auto-injector that will allow medicine to enter into the bloodstream of a a seizing patient before the medicine of an IV begin to work. They will be testing both methods.

The UK research team was selected along with 16 other prominent research institutions across the nation to conduct the emergency medicine trial known as RAMPART (Rapid Anticonvulsant Medication Prior to Arrival Trial) within the Neurological Emergencies Treatment Trials (NETT) Network. The network, formed by the National Institutes of Health, conducts large, simple clinical trials to reduce the burden of very acute injuries and illnesses affecting the brain, spinal cord, and peripheral nervous system.

For more on the story, read here.

University of Texas Gives $100,000 in Grants for Clinical Trials

South Texas children suffering from Leukemia may have been given $100,000 by the University of Texas to get access to clinical trials, through the University of Texas Health Center. According to mysanantonio.com, the $100,000 grant from the National Cancer Institute will provide a patient navigator at the UT Health Science Center's Regional Academic Health Center in Harlingen who will focus his or her time developing and distributing information about trials that are available to young leukemia patients.

What do you think the impact of this grant will have on the study of leukemia? Do you think other organizations will follow suit? Post your thoughts here.

Patient Recruitment through Social Media

Yesterday, we posted that patient recruitment is a huge factor that causes biotechnology companies to run years behind on their timelines. Shahid Shah’s latest post on The Healthcare IT Guy discusses an easier, less expensive and time-saving alternate approach to traditional patient recruitment practices.

We’ve all heard of web 2.0 and social media by this time, but who would have known that patient recruitment could be done through social networking platforms. TrialX, which is a healthcare IT startup, has done a great job of using Google’s and Microsoft’s health platforms available to match participants to relevant clinical trials based on their personal health information. I look forward to when TrialX will completely integrate with Microsoft Health Vault and Google Health making it even easier for patients and investigators to find each other.

This trend will interesting to see as more and more healthcare companies being adopting web 2.0 patient recruitment methods in their practices.

Patient recruitment contributes to delays in biotechnology timelines

According to the Courier Mail in Australia, patient recruitment is one of the factors that causes biotechnology companies to run months, sometimes even years, behind on their time lines. The article suggests that a shortage of patients may be caused by the numerous competitive drugs in development.

Although running on time is a difficult thing to do, Graeme Wald, an analyst at Wilson HTM, said the smaller the trial, the lest likely there was to be a great time delay. Companies must follow ethics boards, work with doctors and find individuals that fit their target patient group.

Other things causing delays in the time lines of clinical trials: competitors' lawsuits, management changes, funding constraints or arguments with regulators.

Drug Money: Risky Economy Draws More Clinical Trial Participants

In Yesterday's show, WNYC's Brian Lehrer discussed the rise in Clinical Trials participants with the decline of the American economy.





Forbes/AP also covered this issue.

Do you think that its safe for the industry to see a rise in participants because of the slow economy? With fears that Clinical Trials and organizations could be seen as predators, what precautions should organizations take?

Covance Names Three New Senior Executives

According to this article in Clinical Trials Today, Covance has added three new senior executive positions to its services team. Covance has appointed Glynis Neagle, M.D., vice president for medical affairs; Robert Bader, director for product safety services; and Thomas Noto, vice president for regulatory affairs.

All three have over 15 years of experience in the clinical trials industry. It will be exciting to see what changes that they will bring to the table.